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FDA Cleared Platelet Rich Fibrin (PRF) Kit

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Understanding the FDA-Cleared PRF Kit: A 15mL Tube

Platelet Rich Fibrin (PRF) is a fibrin matrix where platelet cytokines, growth factors, and cells are released and after a specific period of time.

One significant difference between FDA-Cleared PRF and platelet-rich fibrin is that no anticoagulant is used during processing PRF to keep the platelet yield as natural as possible. The natural fibrinogen within our blood is converted to fibrin by thrombin in the early stages of clot formation, creating a spongy fibrin matrix that activates the platelets and allows for a slow release of growth factors, starting the tissue healing process.

Platelet Rich Fibrin (PRF) stands as a FDA cleared alternative to Platelet Rich Plasma. PRF is an all-natural, autologous solution to treat many body areas. Properly harvested PRF has platelets, fibrin, and white blood cells, which help achieve wound healing, collagen production, and improved elasticity, along with many growth factors. PRF contains a very high concentration of white blood cells, fibrin, and a small number of regenerative cells found circulating in our bloodstream. PRF becomes a viscous gel after 15 to 20 minutes of being isolated and quickly after being injected into the body. The product is used as a stand-alone solution and scaffold for other injectables.

PRF is spun at a slower speed than PRP so that the layers of the blood do not separate as distinctly. This allows some white blood cells and regenerative cells to remain within the platelet layer collected for treatment. Thus, PRF has more healing factors than is typically seen in PRP. In addition, the lower spin speed causes less trauma to the individual cells of the blood, allowing more regenerative cells to remain in the final PRF product.

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FAQs on FDA-Cleared PRF Kits

What is a PRF kit?

A PRF kit is a medical device that is used to prepare Platelet Rich Fibrin (PRF) from a patient’s own blood. PRF is a concentrate of platelets and growth factors that can be used to promote healing in various medical procedures.

What is the FDA clearance for PRF kits?

The FDA clearance for PRF kits means that the device has been reviewed by the FDA and has been found to be safe and effective for its intended use. The clearance indicates that the manufacturer has provided evidence to demonstrate that the device is substantially equivalent to other legally marketed devices.

What are the benefits of using a FDA cleared PRF kit?

Using a FDA cleared PRF kit ensures that the device has been evaluated and found to be safe and effective for its intended use. This can provide patients and healthcare providers with confidence in the quality of the device and its ability to produce consistent results.

What medical procedures can PRF be used for?

PRF can be used in a variety of medical procedures, including oral surgery, orthopedic surgery, plastic surgery, and wound healing.

Is PRF safe?

PRF is derived from a patient’s own blood, so there is a low risk of infection or allergic reaction. However, as with any medical procedure, there are some risks involved. Patients should discuss the risks and benefits of PRF treatment with their healthcare provider.

How is PRF prepared using a PRF kit?

A small amount of the patient’s blood is drawn and processed using the PRF kit. The PRF is then collected and can be applied to the treatment area as needed.

How long does it take to prepare PRF using a PRF kit?

The process of preparing PRF using a PRF kit typically takes less than an hour, depending on the specific device and procedure being used.

Are there any special precautions that need to be taken when using a PRF kit?

Healthcare providers should follow the manufacturer’s instructions for use and take appropriate precautions to prevent contamination and ensure the safety of the patient. Patients should also be informed of any specific instructions or precautions they need to follow before or after the procedure.

How can I find a healthcare provider who uses a FDA cleared PRF kit?

Patients can ask their healthcare provider if they use a FDA cleared PRF kit, or they can contact the manufacturer of the device for a list of providers who use their product.

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